Vaginal prolapse changes the position of the vagina, which can lead to discomfort, urinary incontinence, and incomplete emptying of the bladder. In severe cases, vaginal prolapse conditions can even cause the vagina to become positioned outside of the body.
In a normal female body, the levator ani muscles close the pelvic floor and support the vagina. This results in little force being applied to the fascia and ligaments that support the vagina. Increases in abdominal pressure, failure of the muscles to keep the pelvic floor closed, and damage to ligaments and fascia can all contribute to the development of prolapse. Because, childbirth can lessen the strength of relevant connective tissue as well as the strength of surrounding muscles, it has been implicated as causing vaginal prolapse.
However, studies have shown that a majority of prolapse cases occur years after childbirth, suggesting that factors other than injury from childbirth contribute to the disease. Indeed, menopause accounts for more instances of prolapse than injury from childbirth. This trend suggests that ovarian steroids, especially estrogen, greatly influence the strength of pelvic floor connective tissues.
In order to treat weakening after menopause, a woman may use hormone replacement therapy or vaginal estrogen cream. However, women are generally discouraged from using long-term hormone replacement therapy because of associated health risks. Vaginal estrogen cream is thought to be a lower-risk treatment than hormone replacement therapy or estrogen alone because vaginal estrogen cream is low-dose and has a localized effect. However, the vaginal estrogen cream must be manually applied by the patient as directed, e.g., daily. Additionally, the vaginal estrogen cream is messy during application and use.
Another pelvic disorder that can occur in patients is referred to as urinary incontinence or involuntary loss of urinary control, which is a problem that afflicts men, women, and children of all ages. A variety of treatment options for incontinence are currently available. Some of these include external devices, behavioral therapy (such as biofeedback, electrical stimulation, or Kegel exercises), and prosthetic devices.
Recently, crosslinked bovine collagen has been used as a bulking agent to treat incontinence with symptomatic improvement in many patients. However, more than one injection treatment session is required to achieve satisfactory results. Furthermore, crosslinked collagen causes local tissue hypersensitivity due to the chemical used to crosslink the collagen. There is a need for a bulking agent treatment that eliminates multiple injection sessions and does not cause tissue hypersensitivity.